Brain Alterations Based on Multiplex MR Imaging in Nasopharyngeal Carcinoma Patients After Treatment, and Their Correlation With Clinical Cognitive Scores. (NPC)

June 7, 2025 updated by: Dan Liu, Hubei Cancer Hospital

Brain Alterations Detected by Multiplex MR Imaging in Nasopharyngeal Carcinoma Patients After Treatment

The objective of this study is to examine the potential impact of the treatment before, during, and/or after radiotherapy on the brain in patients with nasopharyngeal carcinoma (NPC) using Multiplex (MTP) MR imaging sequence, which generate multiple contrasts with one-time scan. We aimed to investigate the altered MTP parameters and their correlation with clinical cognitive scores before and after the treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in the head and neck region. Radiotherapy is the primary treatment for NPC patients, particularly those with T3 and T4 stages. However, radiotherapy often induces brain changes during the acute phase, early delayed phase, or late delayed phase, which may even lead to temporal lobe brain injury and subsequent cognitive impairment. Conventional magnetic resonance imaging (MRI) typically fails to detect corresponding radiological alterations in the brain regions affected by these delayed reactions, even when cognitive dysfunction manifests in patients as early as 6 months post-radiotherapy, so as the other treatment. Previous structural MRI studies (e.g., diffusion tensor imaging [DTI], voxel-based morphometry [VBM]) and resting-state functional MRI analyses (e.g., regional homogeneity [ReHo], functional connectivity [FC], graph theory-based methods) have demonstrated that subtle structural changes and functional abnormalities can be observed prior to apparent radiological changes in NPC patients post-radiotherapy. Additionally, radiomics models based on machine learning have shown promise in predicting early radiation-induced brain injury. However, conventional MRI sequences provide limited imaging information, involve cumbersome and complex data processing, and cannot simultaneously integrate multiple imaging modalities or analyze diverse parameters in a single scan. Therefore, developing a novel MRI imaging technique capable of rapidly, simply, and efficiently detecting induction/radiation-induced brain injury or necrosis in NPC patients during the early stages remains a critical challenge for improving survival outcomes and prognosis in clinical practice.

Multiparametric quantitative magnetic resonance imaging (MulTipLex, MTP) is an emerging technique that enables simultaneous acquisition of multiple contrast mechanisms and quantitative physicochemical parameters in a single scan. This technology has been widely applied in the diagnosis and quantitative analysis of neurological disorders such as Alzheimer's disease, Parkinson's disease, temporal lobe epilepsy, and tuberous sclerosis. It has also been utilized for prognostic prediction of cerebral infarction and integrated with multimodal imaging (e.g., PET-MRI, nuclear medicine) to assist in the staging of nasopharyngeal carcinoma, prostate cancer, and cervical cancer. Notably, MTP offers rapid imaging acquisition, mature technical workflows for brain segmentation and quantitative analysis, and comprehensive data fusion capabilities. To date, no studies have investigated the application of MTP in evaluating induction/radiation-induced cognitive dysfunction following NPC before, during, and/or after radiotherapy.

All patients underwent MTP imaging and Montreal Cognitive Assessment (MoCA) tests between different treatment courses.All MRI data were acquired using a 3.0 T MRI scanner (uMRI 790; United Imaging Healthcare, Shanghai, China) equipped with a 32-channel phased-array head coil. A single MTP scan allowing for the acquisition of multiple contrasts, including aT1W, SWI, cPDW, cT1w, T2Star, T1Map, PDMap, R2Star, and quantitative susceptibility mapping (QSM), was collected for each subjec.The MTP data were analyzed using BrainTool software. Then a single-group paired t-test, Pearson's correlations,a two-sample t-test, Receiver operating characteristic curve (ROC) analyses were utilized to analyse those MTP data and clinical data.

We hypothesis the MTP MR sequence can effectively evaluate brain alterations and cognitive impairment in NPC patients following their teratment.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Department of Radiology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients

Description

Inclusion Criteria:

  • pathological evidence of NPC (stages III-IV at diagnosis according to the 8th edition of the UICC/AJCC staging system for NPC)
  • right-handed
  • prepared to receive treatments
  • prepared to receive the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

  • brain invasion
  • brain tumor or atrophy, neural-associated diseases, a history of brain surgery
  • any current medications that may affect cognitive function
  • inability to attend MRI scanning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
before(pre-) and after (post-) treatment groups
The pre-treatment group refers to before treatment, while the post-treatment group refers to after treatment.
Radiation: Changes in the brain MTP parameters after radiotherapy
Our study explores the changes in brain MTP parameters and their correlation with clinical cognitive scores before and after chemotherapy and/or radiotherapy in patients with NPC. We investigates MRI-derived multiparametric imaging biomarkers (MTP) as predictive biomarkers for chemotherapy/radiotherapy-induced cognitive decline in nasopharyngeal carcinoma, aiming to optimize neurotoxicity risk stratification and guide personalized neuroprotective interventions in precision oncology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume
Time Frame: 3 months
the brain volume changes after treatment in NPC patients
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Cancer Hospital

Investigators

  • Study Director: Zilong Yuan, MD, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Study Chair: Dan Liu, MD, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 30, 2025

First Submitted That Met QC Criteria

May 30, 2025

First Posted (Actual)

June 8, 2025

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LLHBCH2023YN-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The raw/processed data required to reproduce these findings cannot be shared at this time as the data also forms part of an ongoing study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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